Dietary Supplement Labeling Act draws opposition from CRN

WASHINGTON — The dietary supplement industry last week took another legislative knock to the chin as it was associated with controversy surrounding mislabled conventional foods, specifically Lazy Cakes, a brownie that contains the dietary ingredient melatonin and purports to be a dietary supplement.

Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., on June 30 introduced the Dietary Supplement Labeling Act, legislation designed to “curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the [Food and Drug Administration].”

The Council for Responsible Nutrition issued a release opposing the measure, describing it as “a misguided bill that doesn’t address the concerns raised by Sen. Durbin, but instead creates more bureaucracy for an already resource-challenged agency, and more red tape and costs for industry while doing nothing to further protect consumers from his concerns.”

The legislation would require the FDA to establish a clear definition of which products are foods and should be regulated as such, and which products are meant to be health aids and should be regulated as dietary supplements. The legislation also would require dietary supplement manufacturers to register dietary supplement products to the FDA and provide a description of each dietary supplement, a list of ingredients and a copy of the label. Additionally, the new law would require product labels to include warnings associated with adverse events of specific ingredients, weight of those ingredients per serving and a batch number for easier recall.

“The bill contains duplicative requirements that already exist under current law that gives [the] FDA the proper legal authority to take action to protect consumers and maintain safety standards,” CRN president and CEO Steve Mister said. “[The] FDA needs to continue working toward becoming a more efficient steward of its resources, and we continuously call on the agency to use its power under the law. We urge Sen. Durbin to join us in that effort.”

Last month, Durbin raised concerns with the FDA about baked goods — such as Lazy Cakes, Kush Cakes and Lulla Pies — containing melatonin that, to the senator’s understanding, do not require approval by the FDA for use as additives in food because they are marketed as dietary supplements.

In January 2010, the FDA issued a warning letter to the manufacturer of Drank for selling a beverage containing melatonin, Durbin noted, and the manufacturer responded by changing the labeling of Drank from a “beverage” to a “dietary supplement” which do not require approval by the FDA for use as additives in food.

“Walk down the aisle of your local convenience store and you will see products targeting young people with names like Lazy Cakes, Drank and Monster Energy Drink,” Durbin stated. “These products market themselves as dietary supplements that are safe ways to relax or get a boost of energy, when in reality they are foods and beverages taking advantage of the more relaxed safety standards for dietary supplements. My bill would help curb this unsafe practice.”

“It’s important to note most products labeled as dietary supplements are legitimate health aids,” Durbin said. “I take a daily vitamin just as millions of Americans do. … My gripe is not with the array of vitamins available at health stores across the nation; my gripe is with products labeled as ‘dietary supplements’ whose ingredients have not been deemed safe by the FDA but are found on store shelves right next to conventional food and beverages. The current system favors the manufacturers of these products to the detriment of consumers — and that needs to change.”

In response, Mister said, “CRN has worked with Sen. Durbin in the past to pass legislation that allows consumers to safely access products that can help to promote a healthier lifestyle, and we hope to be able to find future common ground with the senator. But not with this bill.”

NEENAH, Wis. — Santal Solutions last week announced its dietary supplement Assurance Blood Health Support has gained distribution through Rite Aid and Walgreens.

“We are excited that Assurance Blood Health Support is on the shelves of major retailers,” Santal president Dennis Torkko said. “This reinforces the strength of the product and provides an all-natural option for those individuals that are concerned about blood sugar, cholesterol and triglyceride levels.”

According to the company, Assurance Blood Health Support helps stabilize and balance blood sugar, cholesterol and triglyceride levels that already are within the normal range.

The active ingredient is Gymnema sylvestre, an herb found in the Indian subcontinent.

Assurance Blood Health Support recently changed its name from OmSanA as part of an overall rebranding to better reflect consumer’s trust and confidence in the product. Package graphic and descriptive content also were updated, the company stated.

ProPhase faces NASDAQ delisting

DOYLESTOWN, Pa. — ProPhase Labs on Tuesday announced that it received a letter from the NASDAQ Stock Market indicating that the company no longer is in compliance with NASDAQ listing rules because the closing bid price per share of its common stock has dropped below $1 per share for 30 consecutive trading days.

ProPhase will have until Dec. 27 to push its stock price above $1 for a minimum of 10 consecutive trading days to regain compliance or risk being delisted.

ProPhase stated that all options were on the table to resolve the matter, including a possible reverse stock split.

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